Identity
- Trade Name
- 4CM Tungsten Needle Ext Ins; No Coat; 2.75"; Blue Ins; Black Ext Ins-PL FDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- 4CM Tungsten Needle Ext Ins; No Coat; 2.75"; Blue Ins; Black Ext Ins-PL FDA UDI
- Model / Reference
- 20102SPI FDA UDI
- Description
- 4CM Tungsten Needle Ext Ins; No Coat; 2.75"; Blue Ins; Black Ext Ins-PL FDA UDI
Identifiers
- Catalog Number
- 20102SPI FDA UDI
- Primary DI / UDI-DI
- 00787551035346 FDA UDI
- 510(k) Number
- K081647 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Models / Variants
- 4CM Tungsten Needle Ext Ins FDA UDINo Coat FDA UDI2.75" FDA UDIBlue Ins FDA UDIBlack Ext Ins-PL FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Category: Open-surgery electrosurgical electrode, monopolar, single-use
4CM Tungsten Needle Ext Ins - No Coat by Xodus Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — 5 models — regulatory data on deviCERTS
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Also classified as Open-surgery electrosurgical electrode, monopolar, single-use.
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Cleared under the same submission
K081647 also covers:
- Medichoice — OWENS & MINOR DISTRIBUTION, INC.
- Medichoice — OWENS & MINOR DISTRIBUTION, INC.
- Medichoice — OWENS & MINOR DISTRIBUTION, INC.
- Medichoice — OWENS & MINOR DISTRIBUTION, INC.
- Medichoice — OWENS & MINOR DISTRIBUTION, INC.
- Medichoice — OWENS & MINOR DISTRIBUTION, INC.
- Medichoice — OWENS & MINOR DISTRIBUTION, INC.
- Medichoice — OWENS & MINOR DISTRIBUTION, INC.
- Medichoice — OWENS & MINOR DISTRIBUTION, INC.
- Medichoice — OWENS & MINOR DISTRIBUTION, INC.
- Medichoice — OWENS & MINOR DISTRIBUTION, INC.
- Medichoice — OWENS & MINOR DISTRIBUTION, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Xodus Medical, Inc.
Sources (1)
- FDA UDI a2b52f1f-1a18-4530-9164-bad7aca4b9db 36 fields · synced Jun 1, 2026